NFAT-Dependent Cytokine Gene Expression for Immune Monitoring in Kidney Transplant Patients

This is a single center randomized controlled trial investigating the efficacy and safety of
adjusting calcineurin inhibitor (CNI) dosing based on Nuclear Factor of Activating T Cells
(NFAT)-dependent cytokine gene expression as compared to standard of care adjustments based
on trough level. Before any study-related evaluations are performed, the patient must give
written informed consent. Once consent is obtained, a patient's eligibility to participate
in the study will be assessed within 2 weeks of their 6 month management biopsy.
Approximately 40 patients who meet inclusion criteria will be randomized at University of
California, San Francisco (UCSF). Eligible patients include any patient maintained on triple
therapy with tacrolimus, mycophenolate mofetil ,and prednisone who has had no prior
rejection episodes and who has undergone a 6 month management kidney biopsy that shows no
evidence of acute cellular rejection or antibody mediated rejection.

Inclusion Criteria: Eligible patients include any patient maintained on triple therapy
with tacrolimus, mycophenolate mofetil ,and prednisone who has had no prior rejection
episodes and who has undergone a 6 month management kidney biopsy that shows no evidence
of acute cellular rejection or antibody mediated rejection.

Exclusion Criteria: Any patient not maintained on triple therapy with tacrolimus,
mycophenolate mofetil and steroids and/or who had evidence of rejection on 6- month
management biopsy.